Clean Sampling Vehicle

Clean sampling vehicles are suitable for the collection of raw and auxiliary materials for pharmaceutical and sterile preparations. They are widely used for the collection of special materials in industries such as preparations, electronics, precision instruments, meters, and food. In accordance with GMP standards, the sampling vehicles produced by our factory achieve a cleanliness level of 10,000, and the computer components used comply with GB1497-85 (Electric Safety Standard); they also meet the requirements of GB-191 (Packaging Standard).

Secure the sampling vehicle in use, plug in the power, turn on the power and fan switches, and the fan will start operating. Adjust the voltage to 220v (as a general rule), and after the sampling vehicle has been running for 15 minutes, place it into the sampling drum. Once sampling is complete, turn off the fan and power, and return the sampling vehicle to its original position.

Advantages

The product structure is composed of stainless steel plates or electrostatically coated steel plates, controlled by a computer touch point, featuring variable-speed fan with adjustable air volume, equipped with an ultraviolet sterilization lamp, and customizable in size according to customer requirements.

Verification Plan

Application Range

This solution is applicable for the verification of the PQ-715 clean sampling vehicle.

Responsibilities

Equipment Power Department: Responsible for the installation confirmation of clean sampling vehicles.

Quality Control Department QC: Responsible for drafting and implementing the scheme, and ensuring the accuracy of the measured data.

QC Supervisor: Responsible for the implementation and organization of verification work.

QA Verification Administrator: Responsible for managing verification tasks, assisting in drafting verification plans, organizing and coordinating verification activities, summarizing verification results, and drafting verification reports.

Quality Department Manager: Responsible for verifying plans and reviewing reports.

Quality Director: Responsible for approving plans and reports.

Content

Installation Confirmation

Appearance: The painted surface should be smooth and even, with no peeling or flaking of the coating. The decorative curtains should be smooth, vertical, and free of any damage. Inspection Method: Visual inspection.

Inspect the unpacking and acceptance for compliance with requirements and establish a complete equipment file.

Verify if the SOP for the equipment usage has been drafted and if the personnel have been accordingly trained.

Operation confirmed

Swivel Casters: Flexible and reliable. Inspection Method: Visual inspection, and try turning by hand as well.

Illuminance: The illuminance at each point must not be less than 300Lx. Inspection Method: Tested with an illuminance meter, measuring the illuminance at a height of 60cm from the ground, with a total of three points, measured three times at each point.

Purification Efficiency

Dust particle count: Less than 20,000 particles/m³ for particles larger than 5.0μm, and less than 3,500,000 particles/m³ for particles larger than 0.5μm. Testing method: Adjust the wind speed to low, medium, and high, and test with a dust particle counter at a height of 80cm-100cm from the ground. Measure three points per setting, with each point measured three times.

Settling Bacteria: ≤10 colony-forming units (CFUs), measured at three points, with three measurements per point.

Pressure difference: The pressure difference between the inside and outside of the vehicle is greater than 10Pa. Inspection method: Measure the pressure difference using a micropressure difference gauge, with three points measured three times each.